Sub-Q Versus IV Furosemide in Acute Heart Failure

Phase 2/3 Completed 40 enrolled Johns Hopkins University scPharmaceuticals, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, United States Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated heart failure. Half of the patients will receive a subcutaneously administered Furosemide Injection Solution; the other half will receive an intravenous administration of Furosemide Injection.

Timeline

Start: 2016-02
Primary completion: 2017-06
Completion: 2017-07

Outcome

Missed primary endpoint

paper median IV: 1,425 ml; interquartile range [IQR]: 1,075 to 1,950 ml; vs. median SC: 1,350 ml; IQR: 900 to 1,900 ml; p = 0.84 PMID 29226816 ↗

Publications

Gilotra NA, Princewill O, Marino B, Okwuosa IS, Chasler J, Almansa J, Cummings A, Rhodes P, Chambers J, Cuomo K, Russell SD. Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail. 2018 Jan;6(1):65-70. doi: 10.1016/j.jchf.2017.10.001. Epub 2017 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Furosemide	Other / unclassified	80 mg	Subcutaneous